Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Siemens healthcare diagnostics has confirmed low red blood cell control recoveries and low results for red blood cell samples when using the advia centaur systems folate assay with the kit lots of folate ascorbic acid/ascorbic acid diluent 54942 56230 and 70673. the issue is limited to the lot of ascorbic acid diluent in these kits.